SIGMA M— 510(k) K063837

Name: FDA 510(k) clearance K063837
Creator: U.S. Food and Drug Administration
Published: 2007-07-02

Substantially Equivalent

Instrumentarium Dental, Palodex Group OY

FDA 510(k) clearance K063837 for SIGMA M, Substantially Equivalent on 2007-07-02. Applicant: Instrumentarium Dental, Palodex Group OY. Device class: 2.

Clearance details

Applicant: Instrumentarium Dental, Palodex Group OY
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2006-12-26
Decision date: 2007-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuusula, FI

Download summary PDF View on FDA.gov ↗

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